A Phase II Trial Evaluating the Safety of Rapid Infusion of Ofatumumab in Patients with Previously Treated Chronic Lymphocytic Leukemia

Oncologist. 2017 Oct;22(10):1156-e111. doi: 10.1634/theoncologist.2017-0236. Epub 2017 Jul 7.

Abstract

Lessons learned: Ofatumumab infusion reactions can be diminished by escalating the dose rate in individual patients in sequential infusions.

Background: Ofatumumab (OFA) is a fully humanized, anti-CD20 antibody approved for use in chronic lymphocytic leukemia (CLL). The recommended administration requires long infusion times. We evaluated an accelerated infusion regimen of 2 hours.

Methods: The first dose of OFA (300 mg) was given on week 1 day 1 starting at 3.6 mg/hour and doubling every 30 minutes until a rate of 240 mg/hour was reached. If tolerated, the second dose (1,000 mg) was given on week 1 day 3 starting at 50 mg/hour and doubling every 30 minutes until a rate of 800 mg/hour was reached. If tolerated, the third dose (2,000 mg) was given on week 2 day 1 at 800 mg/hour over the first 30 minutes and, if tolerated, at 1,068 mg/hour over the next 90 minutes (goal infusion time: 120 minutes). Subsequent OFA infusions were administered weekly in the same manner for 8 weeks, and then monthly for 4 months.

Results: Thirty-four patients were treated. Most infusion-related reactions occurred during the first and second infusion. Eighty-seven percent (87%) of patients finished the third infusion within 15 minutes of the planned 2 hours and only one had an infusion reaction.

Conclusion: Using this stepped-up dosing regimen, a rapid infusion of OFA is safe and well tolerated.

经验总结

• 通过逐步升高个体患者每次输注的剂量速率可降低Ofatumumab的输注反应。

摘要

背景. Ofatumumab(OFA)是被批准用于治疗慢性淋巴细胞白血病(CLL)的完全人源化抗CD20抗体。推荐的给药量所需的输注时间较长。研究对2小时的加速输注方案进行了评估。

方法. 在第1周第1天给予第一剂OFA(300mg), 起始输注速率为3.6 mg/小时, 每30分钟翻一倍, 直到输注速率达到240 mg/小时。如果可耐受, 则在第1周第3天给予第二剂药物(1 000 mg), 起始输注速率为50 mg/小时, 每30分钟翻一倍, 直到输注速率达到800 mg/小时。如果可耐受, 在第2周第1天给予第三剂药物(2 000 mg), 输注的前30分钟内速率为800 mg/小时, 如果仍能耐受, 则在接下来的90分钟内以1 068 mg/小时的速率给药(目标输注时间:120分钟)。随后以相同的方式每周进行OFA输注给药, 持续8周, 然后每月以相同的方式给药, 持续4个月。

结果. 34名患者接受治疗。大多数输注相关反应在首次或第二次输注时出现。87%的患者在15分钟内完成了原计划持续2小时的第三次输注, 仅1名患者出现输注反应。

结论. 使用这种加速给药方案快速输注OFA是安全和可良好耐受的。

Trial registration: ClinicalTrials.gov NCT01848145.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / pharmacology
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / pharmacology
  • Antineoplastic Agents / therapeutic use*
  • Female
  • Humans
  • Leukemia, Lymphocytic, Chronic, B-Cell / drug therapy*
  • Leukemia, Lymphocytic, Chronic, B-Cell / pathology
  • Male
  • Middle Aged

Substances

  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • ofatumumab

Associated data

  • ClinicalTrials.gov/NCT01848145